An interventional study of Zenflow Spring System in Benign Prostatic Hyperplasia, sponsored by Zenflow, Inc.. Recruiting at 2 sites in Canada. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2021-07-19.
Sponsored by Zenflow, Inc. · Not applicable, Interventional, and Treatment
The objectives of the trial are to demonstrate the safety and performance of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
The purpose of the Zenflow Study (ZEST CAN) is to evaluate the safety, performance and effectiveness of the Zenflow Spring System for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hyperplasia (BPH). It is intended that the features of the Zenflow Spring will provide an effective office-based treatment and management therapy for BPH with little or no side effects.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 40 is below the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Zenflow, Inc. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any of the following, taken from a single uroflowmetry reading:
Taking one of the following within 2 weeks of pre-treatment (baseline) evaluation:
Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receives intervention with the Zenflow Spring System.
Device: Zenflow Spring System
The Zenflow Spring is a nitinol urethral implant for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hypertrophy (BPH). The device is intended to be a permanent implant however it may be removed if necessary.
Successful placement of the Zenflow Spring Implant
Number of successful deployments and procedural successes for the Zenflow System to implant the Spring device in the OR, or in an out-patient clinical setting as compared to total treatment attempts.
Time frame: Day of discharge up to 7 days following device placement
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) using the International Prostate Symptom Score
At 3 months, achieve at least 30% mean improvement in International Prostate Symptom Score (IPSS) compared to baseline. The patient is asked to respond to 7 questions related to his urinary health using a rating scale of 0 to 5 where zero is excellent and 5 is the worst possible. The responses to the 7 questions are tallied for a total IPSS score.
Time frame: 3 month
Need for urinary catheterization
Achieve \< 12% rate of extended post-operative urinary catheterization, defined as an occurrence of a subject requiring catheterization within the first 3 days as part of a postoperative management for inability to void, for greater than 7 days.
Time frame: 7 days after the procedure
Incidence of procedure or device related serious adverse events
Achieve \< 12% rate of device or procedure related SAEs through discharge and 30 days follow up.
Time frame: 30 days after the procedure
Assessment of Sexual Health Assessment: Change in sexual health measured by change in the Sexual Health Inventory for Men (SHIM) questionnaire score
The patient selects the most appropriate response to 5 questions about his sexual health. Each response has an assigned value between 1 and 5. The numeric values are tallied for a total score.
Time frame: Baseline, 3, 6, 12, 24, 36, 48, & 60 months
Assessment of Pain, evaluated using a Visual Analog Score (VAS) of 1 to 10
Patient describes pain on a Visual Analog Scale (VAS). The scale is a line labeled 1 at the far left indicating minimal pain and 10 on the right, which is maximum pain.
Time frame: Baseline, interoperative (if conscious sedation used), immediately post-treatment, 2 weeks, 1 and 3 months
Assessment of Adverse Events
Rate of adverse events related to the procedure or device.
Time frame: Up to 5 years
Assessment of Clavien-Dindo events
Proportion of subjects with procedure or device related adverse events classified as Clavien-Dindo Grade 3 or higher or any event resulting in persistent disability evidenced through 3 months post treatment.
Time frame: Up to 5 years
Assessment of PSA
Change in PSA from baseline through 12, 24, 36, 48, \& 60 months post treatment.
Time frame: Up to 5 years
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
The patient is asked to respond to 7 questions related to his urinary health using a rating scale of 0 to 5 where zero is excellent and 5 is the worst possible. The responses to the 7 questions are tallied for a total score
Time frame: Baseline, 2 weeks, 1, 6, 12, 24, 36, 48, & 60 months
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Improvement in flow of urine as measured by uroflowmetry machine.
Time frame: Baseline, 2 weeks, 1, 3, 6, 12, 24, 36, 48, & 60 months
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Incidence of increase in dosage or initiation of new medication to treat symptoms of BPH.
Time frame: Up to 5 years
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Incidence of repeat treatment.
Time frame: 24 to 60 months
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2021 (actual). Primary completion is estimated for Dec 2025, 57 months after the start.
Of 51 industry-sponsored interventional studies with no phase under Prostatic Hyperplasia, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 50. This study's planned 57 months is above that.
Counting every sponsor, half of 203 studies reached it within 26 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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Zenflow, Inc.